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Oximeter
EUDAMEDClass IIa (EU MDR)
Ref JZK-307Model JZK-301，JZK-303, JZK-305, JZK-307
Identity
- Trade Name
- Oximeter EUDAMED
- Device Name
- Oximeter EUDAMED
- Model / Reference
- JZK-301，JZK-303, JZK-305, JZK-307 EUDAMEDJZK-307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922119300229 EUDAMED
- Basic UDI-DI
- 69221193XSY EUDAMED
- Direct Marketing DI
- 06922119300229 EUDAMED
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oximeter by Shenzhen Zhengkang Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69221193XSY | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen ZhengKang Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038997
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED cd53d8da-82ff-4add-8500-31e34a35f192 61 fields · synced May 23, 2026